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PET-Heat: Characterization of Myocardial Blood Flow During Heat Exposure

Sponsor
Montreal Heart Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT04549974
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
23.2
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the increase in myocardial blood flow during heat exposure and how this response is affected by age and coronary artery disease.

Condition or Disease Intervention/Treatment Phase
  • Other: Heat exposure
 N/A

Detailed Description

As a result of climate change, heat waves are more frequent and of longer duration. These heat waves are associated with a higher risk of hospitalization and mortality in vulnerable populations such as people with cardiovascular disease or cardiovascular risk factors. It has been hypothesized that this observation may be explained by the cardiovascular demands imposed by heat exposure.

Heat exposure requires increased cardiac work that may place individuals with cardiovascular disease at risk of ischemic events if the metabolic demand is not compensated by adequate blood supply. However, the extent to which cardiac work increases during heat exposure remains unknown. The aim of this study is to test the hypothesis that heat exposure increases myocardial blood flow and that this increase is affected by age and coronary artery disease.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Characterization of the Increase and Distribution of Myocardial Blood Flow During Heat Exposure
Actual Study Start Date :
Aug 25, 2020
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Jul 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Passive heat exposure

Other: Heat exposure
Participants will be exposed to heat exposure via a water-perfused suit to increase internal body temperature by 1.5 degrees Celsius.

Outcome Measures

Primary Outcome Measures

  1. Global myocardial blood flow [Change from baseline to an increase in internal body temperature of 1.5 degrees Celsius, estimated average = 90 minutes]

    Measured by PET imaging with 82rubidium

Secondary Outcome Measures

  1. Myocardial blood flow distribution [Change from baseline to an increase in internal body temperature of 1.5 degrees Celsius, estimated average = 90 minutes]

    Measured by PET imaging with 82rubidium

  2. Heart rate [Change from baseline to an increase in internal body temperature of 1.5 degrees Celsius, estimated average = 90 minutes]

    Measured by electrocardiogram

  3. Systolic and diastolic blood pressure [Change from baseline to an increase in internal body temperature of 1.5 degrees Celsius, estimated average = 90 minutes]

    Measured by automated auscultation of the brachial artery

  4. Body weight [Measured before and after heat exposure, estimated average = 120 minutes]

    Measured with a scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria for Healthy Participants:

  • Age between 18-40 years or 60-80 years

  • Non-smoker (≥1 year)

  • Non-diabetic

  • Normal kidney function

  • Body Mass Index <30 kg/m2

  • Resting blood pressure <140/<90 mmHg

  • Resting heart rate <100 bpm

Inclusion Criteria for Participants with Coronary Artery Disease:

  • Age between 60-80 years old

  • History of angiographic coronary disease (≥70% arterial diameter narrowing of at least one major epicardial coronary artery) and/or prior coronary revascularization and/or documented prior acute coronary syndrome and/or perfusion defect during stress testing

  • Stable medications (≥4 weeks) prior to enrollment

Exclusion Criteria for Healthy Participants:

  • Diagnosis of heart, vascular, respiratory, neurological or metabolic disease and/or a prescription of medication for the treatment of these diseases

  • Pregnancy or lactation

  • Dyslipidemia not controlled by medication

Exclusion Criteria for Participants with Coronary Artery Disease:

  • Recent hospitalization (<3 months) related to coronary artery disease

  • Unstable angina (<3 months)

  • Recent coronary artery bypass surgery (<3 months)

  • Left branch block

  • Ejection fraction <40% and/or clinical signs of heart failure

  • Severe valvular heart disease

  • Hypertension not controlled by medication

  • Diabetes not controlled by medication and/or serious complications related to diabetes

Contacts and Locations

Locations

Site City State Country Postal Code
1 Montreal Heart Institute Montréal Quebec Canada H1T1C8

Sponsors and Collaborators

  • Montreal Heart Institute

Investigators

  • Principal Investigator: Daniel Gagnon, PhD, Montreal Heart Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Daniel Gagnon, Principal Investigator, Montreal Heart Institute
ClinicalTrials.gov Identifier:
NCT04549974
Other Study ID Numbers:
  • ICM 2020-2719
First Posted:
Sep 16, 2020
Last Update Posted:
May 12, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Daniel Gagnon, Principal Investigator, Montreal Heart Institute
Heat
PET imaging
Myocardial blood flow
Additional relevant MeSH terms:
Coronary Artery Disease

Study Results

No Results Posted as of May 12, 2021